Table 3.
Adverse Events | Prednisolone (n=25) | Tacrolimus (n=27) |
---|---|---|
Total | 18 (4 SAEa) | 20 (3 SAEb) |
Infections requiring antibiotics | 6 | 5 |
URTI requiring antibiotics | 2 | 3 |
LRTI requiring antibiotics | 3 (1 SAE) | 1 SAE |
Urinary tract infections | 1 | |
Infective diarrhea | 1 | |
Vaginal candidiasis | 1 | |
Musculoskeletal pain | 4 | |
Gastrointestinal symptoms | 1 SAE | 5 (1 SAE) |
Headache | 2 (1 SAE) | 1 |
Gum pain | 2 | |
Weight gain | 1 | |
Low mood | 2 | |
Acneiform rash | 2 | |
Hyperglycemia | 1 | 1 |
Uncontrolled hypertension | 1 SAE | |
Deranged LFTs | 1 | |
Traumatic limb fracture | 2 (1 SAE) |
SAE, serious adverse event; URTI, upper respiratory tract infection; LRTI, lower respiratory tract infection; LFT, liver function test.
SAEs recorded in the prednisolone cohort were one admission with perforated diverticular ulcer, one episode of severe headache requiring investigation (no organic cause identified), one patient with traumatic fractured radius, and one patient with lower respiratory tract infection requiring intravenous antibiotics and supplemental oxygen.
The SAE recorded in the tacrolimus cohort were one admission with uncontrolled hypertension, one admission with diarrhea and rash 2 days into treatment, and one admission with lower respiratory tract infection.